EP4233977A2 - Access visualization systems - Google Patents
Access visualization systems Download PDFInfo
- Publication number
- EP4233977A2 EP4233977A2 EP23181476.5A EP23181476A EP4233977A2 EP 4233977 A2 EP4233977 A2 EP 4233977A2 EP 23181476 A EP23181476 A EP 23181476A EP 4233977 A2 EP4233977 A2 EP 4233977A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- dilator
- guide tube
- endoscope
- dilation
- dilator member
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000012800 visualization Methods 0.000 title claims description 32
- 230000010339 dilation Effects 0.000 claims description 44
- 238000003780 insertion Methods 0.000 claims description 8
- 230000037431 insertion Effects 0.000 claims description 8
- 239000012530 fluid Substances 0.000 claims description 6
- 238000004891 communication Methods 0.000 claims description 5
- 238000000034 method Methods 0.000 abstract description 55
- 210000001519 tissue Anatomy 0.000 description 46
- 238000002224 dissection Methods 0.000 description 15
- 230000015271 coagulation Effects 0.000 description 12
- 238000005345 coagulation Methods 0.000 description 12
- 239000000523 sample Substances 0.000 description 12
- 210000000115 thoracic cavity Anatomy 0.000 description 7
- 238000003384 imaging method Methods 0.000 description 4
- 210000003516 pericardium Anatomy 0.000 description 4
- 206010003658 Atrial Fibrillation Diseases 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 210000000056 organ Anatomy 0.000 description 3
- 238000007792 addition Methods 0.000 description 2
- 230000000916 dilatatory effect Effects 0.000 description 2
- 239000000835 fiber Substances 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 210000004872 soft tissue Anatomy 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 239000012780 transparent material Substances 0.000 description 2
- 230000000007 visual effect Effects 0.000 description 2
- 206010028980 Neoplasm Diseases 0.000 description 1
- 208000002847 Surgical Wound Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 230000009977 dual effect Effects 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000002427 irreversible effect Effects 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 238000002324 minimally invasive surgery Methods 0.000 description 1
- 238000002355 open surgical procedure Methods 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 238000011477 surgical intervention Methods 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 206010047302 ventricular tachycardia Diseases 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/313—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00064—Constructional details of the endoscope body
- A61B1/00071—Insertion part of the endoscope body
- A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
- A61B1/00087—Tools
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00147—Holding or positioning arrangements
- A61B1/00154—Holding or positioning arrangements using guiding arrangements for insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
Definitions
- Scope based surgical tools provide surgeons with an ability to view a surgical site through a lens/fiber optic/camera of the scope and also provide an ability to access the surgical site through a working channel of the tool.
- a scope permits the surgeon to access internal body tissue by passing the scope through a small diameter opening, port, or trocar placed in a surface of the body.
- an endoscope as a scope-based device.
- inventive devices and methods described herein specifically include the use of any number of scope based devices generally similar to an endoscope; for example, any type of rigid or flexible tube with or without a light delivery system and a visualization source that transmits an image to the viewer, and (optionally) a working channel or lumen that permits delivery of an additional device through the scope.
- U.S. Patent No. 5,205,816 (the entirety of which is incorporated by reference) teaches a simple blunt dissector having a cannulated single lumen device with a mandrel inserted into the device for carrying a simple textured cloth that provides a textured surface.
- U.S. Patent No. 5,205,816 (the entirety of which is incorporated by reference) teaches a simple blunt dissector having a cannulated single lumen device with a mandrel inserted into the device for carrying a simple textured cloth that provides a textured surface.
- the additional blunt dissector requires an additional entry port or must be exchanged with other tools that are advanced through the entry site.
- a physician must manipulate a scope as well as the blunt dissection device.
- scopes are being adapted to assist in the dissection of tissue to eliminate the need for an additional dissection device.
- Many conventional devices rely upon balloon-type structures for dissection of tissue via expansion of the balloon or close-ended obturator-type structures that dissect via dilation via insertion of the closed end.
- U.S. Patent No. 6,989,018 to Fogarty et al. discloses a balloon dissection apparatus having an elongate balloon that performs the tissue dissection.
- this dissection relies upon somewhat uncontrollable expansion of the balloon (as the internal balloon pressure increases)
- the physician typically has less control over the amount of tissue dissection as compared to using a non-expanding structure to physically dissect tissue.
- U.S. Patent Nos.: 6,592,604 ; 6,752,756 ; and 7,001,404 describe tissue dissection devices having with closed ends (where such ends act as obturators). The closed ends are generally translucent to allow for visualization therethrough. Yet, dissection of tissue occurs via dilation of the tissue using the closed end.
- U.S. Patent No. 7,300,448 discloses a combination balloon dissector having an obturator associated with the balloon dissector assembly.
- the balloon dissection or dissection via obturator dilation as described above do not provide the physician with the ability to tease or loosen adjoining tissue for a more controlled dissection of tissue.
- the present method of solving this problem is using an integrated endoscope system, which provides electrophysiologists or interventional cardiologists visualization of the access procedure.
- the benefit of the integrated endoscope system is that it provides a safe and easy seamless passage for entering the pericardial space with visualization to minimize trauma to the heart.
- the integrated endoscope system may provide access to the pericardial space by percutaneous pericardial access.
- the improved methods and devices described herein offer improved access to tissue regions within the body, especially those organs in the thoracic cavity. However, the devices and methods have applicability to any region in the body apart from the thoracic cavity.
- the present system includes an endoscope configured to provide remote visualization; a dilator member having a proximal portion, a distal portion, a distal end, and a dilator passage extending from the proximal portion through the distal end, the dilator member further comprising a dilation surface located about an outer surface at the distal portion, where a profile of the dilator surface increases in size along a proximal direction such that insertion of the dilator portion in an opening in tissue dilates the tissue; a guide tube extending from the distal end of the dilator member and having a guide passage in fluid communication with the dilator passage; and where the endoscope is advanceable through the guide tube passage such that a visualization end of the endoscope can be repositioned within the guide tube.
- the variation of the above system can further include a second endoscope extending through the dilator member and radially offset from the guide tube.
- the second endoscope comprises a second visualization end exiting at a dilation surface of the dilator member.
- Variations of the system can include a configuration where the dilator member is slidable relative to the guide member.
- any portion of the system can be transparent.
- additional variations include portions of the system that are opaque.
- the guide member described herein can be removable from the dilator member or fixed to the dilator member.
- the present disclosure includes a dilation system for use with an endoscope configured to provide remote visualization, the endoscope comprising a visualization end located at a distal portion, the dilation system comprising: a dilator member having a proximal portion, a distal portion, a distal end, and a dilator passage extending from the proximal portion through the distal end, the dilator member further comprising a dilation surface located about an outer surface at the distal portion, where a profile of the dilator surface increases in size along a proximal direction such that insertion of the dilator portion in an opening in tissue dilates the tissue; a guide tube extending from the distal end of the dilator member and having a guide passage in fluid communication with the dilator passage; and where the endoscope is advanceable through the guide tube passage such that the visualization end of the endoscope can be repositioned within the guide tube.
- the present disclosure includes methods for placement of an endoscope adjacent to a target site.
- a method comprises positioning an access device adjacent to an opening in tissue, the access device comprising a guide tube and a dilator member, where the guide tube is coupled to at a distal end of the dilator member; inserting the guide tube of the access device within the opening in tissue; dilating the opening in tissue by advancing the dilator member of the access device through the opening in tissue; and imaging the target site using the endoscope while the endoscope is positioned through the dilator member.
- the method can further include visualizing using the endoscope while inserting the guide tube of the access device within the opening.
- the method includes an opening in tissue which comprises an opening in a pericardial space.
- the method includes a guide tube is transparent and further comprising visualizing through a wall of the guide tube using the endoscope.
- the dilator can be transparent and the method further comprises visualizing through a wall of the guide tube using the endoscope.
- the endoscope is affixed to the dilator member and where imaging the target site using the endoscope while the endoscope is positioned through the dilator member comprises repositioning the dilator member to reposition the endoscope.
- Variations of the method further include advancing a second endoscope through the guide tube.
- the present methods can include the use of any conventional device to assist in accessing the body.
- the methods can further include advancing a guidewire through the opening in tissue and where inserting the guide tube comprises advancing the guide tube over the guidewire.
- Methods and devices described herein provide for improved access of regions within the body using remote visualization, such as endoscopes.
- the improved methods and devices described herein offer improved access to tissue regions within the body, especially those organs in the thoracic cavity.
- the following example discusses the methods and devices as used when a physician accesses a pericardial space within a thoracic cavity of an individual, however, the devices and methods have applicability to any region in the body where the benefits of the methods and procedures can assist in the procedure.
- Scope based surgical tools provide surgeons with an ability to view a surgical site through a lens/fiber optic/camera of the scope and also provide an ability to access the surgical site through a working channel of the tool.
- a scope permits the surgeon to access internal body tissue by passing the scope through a small diameter opening, port, or trocar placed in a surface of the body.
- an endoscope as a scope-based device.
- inventive devices and methods described herein specifically include the use of any number of scope based devices used for remotely viewing an area of tissue generally similar to an endoscope; for example, any type of rigid or flexible tube with or without a light delivery system and a visualization source that transmits an image to the viewer, and (optionally) a working channel or lumen that permits delivery of an additional device through the scope.
- FIG. 1A illustrates a first variation under the present disclosure of an endoscopic system 100 or dilation system 100 (when the endoscope is a stand-alone added component).
- the system 100 includes a dilator member 102 having a distal dilation surface 106 and a dilator passage 108 extending therethrough.
- a guide tube 104 extends distally from the dilator passage 108 allowing for an endoscope 150 to be advanced therethrough.
- the end 110 of the guide tube 104 can be open or can be closed. In the illustrated variation, the end 110 of the guide tube 104 is configured to be atraumatic.
- the components of the system 100 can include any conventional features useful for medical devices and/or procedures.
- the system 100 can be configured for coupling to a visual display 50 for viewing the images transmitted/relayed from the visualization end 152 of the endoscope 150.
- the system can include any number of auxiliary fixtures (such as a fluid source, vacuum source, controller for electrodes/pacing, etc.)
- the guide tube 104 and/or dilator member 102 can have steering capabilities or pre-set shapes to assist in navigating the respective component within tissue.
- FIGS. 1B and 1C illustrate additional variations of systems 100 for navigation of an endoscopic device 150.
- the guide tube 104 can optionally extend through the length of the dilator 102 and can optionally move relative to the dilator 102 as indicated by arrows 112.
- the dilation surface 106 of the variation shown in FIG. 1B can be stepped rather than conical (as shown in FIG. 1A ).
- any atraumatic shape can be used for the dilation surface 106.
- FIG. 1C also illustrates a dilator 102 having an additional dilation feature 114 such as a distensible or non-distensible balloon 114.
- one or more of the components can be configured to assist or improve visualization of a target site by the endoscope.
- the dilator and/or the guide sheath can be fabricated from opaque or transparent materials.
- the dilator and/or guide tube can include a transparent window that assist in visualization by the endoscope.
- FIGS. 2A to 2C illustrate another variation of a dilation system 100 (that can optionally be integrated with an endoscope 160 ).
- a dilator 102 includes a guide tube 100 extending therethrough with the distal end of the guide tube 110 extending beyond the dilation surface 106 of the dilator 102.
- this variation also includes an internal endoscope 160 that is adjacent to the guide tube 110.
- Such a configuration allows the internal endoscope 160 to provide an unobstructed view (via the display 50 ) allowing the physician to visualize the tissue adjacent to the dilation surface 106 as the dilator advances.
- FIGS. 2B and 2C illustrate the end of the dilator 102 shown in FIG. 2A .
- the dilator 102 can include a scalloped opening or one where there are two passages that are parallel.
- the passages 108 and 114 can be joined (as shown in FIG. 2B ) or separated (such as those found in a multi-lumen tube). Additional variations of the dilator opening can include various other shapes.
- the opening 114 provides space for the internal scope (as shown in FIG. 2C ).
- the dilator and/or guide tube may be composed of either opaque or transparent materials.
- the internal scope 160 can be affixed to the dilator as shown in FIG. 2C . Alternatively, the scope 160 can be moveable relative to the dilator 102.
- FIG. 3 shows another variation of the system 100 similar to the one shown in FIG. 2A .
- the system 100 includes two scopes 150 , 160 .
- the dilator member 102 includes an internal scope 160 (either fixed or moveable within the dilator member 102 ).
- An additional scope 150 can be advanced through the guide member 104 as discussed above with respect to FIG. 1A .
- the variation shown in FIG. 3 can include an additional monitor/display 52.
- the image generated by both scopes 150 , 160 can be projected on both monitors or a single monitor.
- FIGS. 4A-4E illustrates a variation of a process of positioning or placing an endoscope using the system described herein.
- a variation of the procedure uses minimal incisions 10 and 12 to access the chest cavity.
- an incision 14 can be made that requires traversing a diaphragm of the individual 1 in order to access the thoracic cavity.
- the procedure can be performed percutaneously.
- alternate variations of the method can occur in an open surgical procedure or with any number of surgical incisions.
- the integrated system can be inserted into the patient through any number of conventionally known access methods.
- FIG. 4B illustrates a heart 4 surrounded by a pericardium 4 in order to demonstrate an example of a process for placement of a scope using the system described herein.
- a commercially available dilator e.g., for renal applications
- a guidewire 22 can be delivered through the needle 20 into the pericardial space.
- a physician can use an expandable cannula to insert the integrated system disclosed herein.
- the physician can use this expandable cannula with an initial insertion profile to minimize the size the pericardial opening to enter the pericardium. Once inserted, the physician expands the expandable cannula to allow for insertion of any of the disclosed integrated endoscope systems.
- FIG. 4C illustrates the state where the physician removes the needle 20 leaving the guidewire 22 in place.
- the physician introduces a system 100 adjacent to the site and advances a guide tube 104 over the guidewire 22 through the pericardial incision 6 and into the pericardial space.
- a first scope 150 can optionally be inserted through the guide tube 104 to assist the physician by allowing for visualization of the in the pericardial space that is otherwise obscured by the pericardium 4.
- the guidewire 22 must be removed to advance the scope 150.
- the guide tube 104 is configured to accommodate both a scope and guidewire.
- variations of the system including an internal scope 160 allow the physician visual access to the region adjacent to the distal end of the dilator member 102 and guide tube 104.
- FIGS. 4D and 4E illustrate examples of a dual scope system and a single scope system, respectively.
- a physician can use an internal scope 160 that is positioned adjacent to a dilation surface 106 of the dilator member 102 for visualization.
- the physician also has the option of using a second scope 150 that passes through the guide tube 104.
- FIG. 4E illustrates an example of the system where the scope 150 is positioned through the guide tube 104.
- the physician can advance the dilator member 102 to further dilate the opening 6.
- the physician can then advance an additional cannula or a hollow sheath the dilator member of the system.
- a commercial dilator can be advanced over the dilator member 102 to permit removal of the dilator member 102 and system to prepare the site for further surgical devices.
- integrated vacuum coagulation probes provided by AtriCure, Ohio, are examples of devices that can be inserted through the openings provided by the systems described above. Such devices are capable of heating the soft tissue until achieving irreversible injury making the soft tissue non-viable and unable to propagate electrical impulses, mutate, or reproduce.
- integrated vacuum coagulation probe embodiments may be in conjunction with the access devices described herein to treat atrial fibrillation, ventricular tachycardia or other arrhythmia substrate, or eliminating cancer in lung, or other soft thoracic tissue by destroying target cells.
- the present invention relates to the following aspects:
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Abstract
Description
- The present application is a non-provisional of
U.S. Provisional Patent Application Number 62/160,997 filed on May 13, 2015 - Methods and devices for access devices to allow improved access in preparation for performing surgical procedures or intervention in areas where collateral damage to sensitive tissue or organs can easily occur. For example, electrophysiologists or interventional cardiologists generally perform procedures under fluoroscopic guidance. However, issues arise when physician access the pericardial space because of their limited viewing capabilities under fluoroscopic guidance.
- Scope based surgical tools (e.g., elongated cannula/tubular devices that allow viewing of internal body tissues) provide surgeons with an ability to view a surgical site through a lens/fiber optic/camera of the scope and also provide an ability to access the surgical site through a working channel of the tool. In some cases, a scope permits the surgeon to access internal body tissue by passing the scope through a small diameter opening, port, or trocar placed in a surface of the body. For convenience, the present disclosure makes reference an endoscope as a scope-based device. However, the inventive devices and methods described herein specifically include the use of any number of scope based devices generally similar to an endoscope; for example, any type of rigid or flexible tube with or without a light delivery system and a visualization source that transmits an image to the viewer, and (optionally) a working channel or lumen that permits delivery of an additional device through the scope.
- In many surgical procedures, the surgeon must also dissect tissue to gain access to the intended target site. For example,
U.S. Patent No. 5,205,816 (the entirety of which is incorporated by reference) teaches a simple blunt dissector having a cannulated single lumen device with a mandrel inserted into the device for carrying a simple textured cloth that provides a textured surface. However, such basic devices are used in addition to the scopes that are used for such minimally invasive procedures. The additional blunt dissector requires an additional entry port or must be exchanged with other tools that are advanced through the entry site. In addition, a physician must manipulate a scope as well as the blunt dissection device. - Increasingly, scopes are being adapted to assist in the dissection of tissue to eliminate the need for an additional dissection device. Clearly, doing so reduces the number of devices that a physician must manipulate in the surgical area as well as the number of devices that are advanced through the body opening/port/incision. Many conventional devices rely upon balloon-type structures for dissection of tissue via expansion of the balloon or close-ended obturator-type structures that dissect via dilation via insertion of the closed end.
- For example,
U.S. Patent No. 6,989,018 to Fogarty et al. (the entirety of which is incorporated by reference herein) discloses a balloon dissection apparatus having an elongate balloon that performs the tissue dissection. However, because this dissection relies upon somewhat uncontrollable expansion of the balloon (as the internal balloon pressure increases), the physician typically has less control over the amount of tissue dissection as compared to using a non-expanding structure to physically dissect tissue. - While obturator type devices avoid the problems with somewhat unpredictable dissection via balloon expansion, such devices are still not optimal. For example,
U.S. Patent Nos.: 6,592,604 ;6,752,756 ; and7,001,404 (the entirety of each patent incorporated by reference herein) describe tissue dissection devices having with closed ends (where such ends act as obturators). The closed ends are generally translucent to allow for visualization therethrough. Yet, dissection of tissue occurs via dilation of the tissue using the closed end.U.S. Patent No. 7,300,448 (the entirety of which is incorporated by reference herein) discloses a combination balloon dissector having an obturator associated with the balloon dissector assembly. - In any event, the balloon dissection or dissection via obturator dilation as described above do not provide the physician with the ability to tease or loosen adjoining tissue for a more controlled dissection of tissue.
- Accordingly, there is a need for improved methods and devices that permit visualization to allow the physicians more comfort in performing various procedures while minimizing the risk of collateral damage to tissue or to the tissue being dissected/dilated.
- In one variation, the present method of solving this problem is using an integrated endoscope system, which provides electrophysiologists or interventional cardiologists visualization of the access procedure. The benefit of the integrated endoscope system is that it provides a safe and easy seamless passage for entering the pericardial space with visualization to minimize trauma to the heart. The integrated endoscope system may provide access to the pericardial space by percutaneous pericardial access.
- The improved methods and devices described herein offer improved access to tissue regions within the body, especially those organs in the thoracic cavity. However, the devices and methods have applicability to any region in the body apart from the thoracic cavity.
- In a first variation, the present system includes an endoscope configured to provide remote visualization; a dilator member having a proximal portion, a distal portion, a distal end, and a dilator passage extending from the proximal portion through the distal end, the dilator member further comprising a dilation surface located about an outer surface at the distal portion, where a profile of the dilator surface increases in size along a proximal direction such that insertion of the dilator portion in an opening in tissue dilates the tissue; a guide tube extending from the distal end of the dilator member and having a guide passage in fluid communication with the dilator passage; and where the endoscope is advanceable through the guide tube passage such that a visualization end of the endoscope can be repositioned within the guide tube.
- The variation of the above system can further include a second endoscope extending through the dilator member and radially offset from the guide tube. In some examples, the second endoscope comprises a second visualization end exiting at a dilation surface of the dilator member.
- Variations of the system can include a configuration where the dilator member is slidable relative to the guide member.
- In order to aid in visualization using the scopes, any portion of the system can be transparent. Similarly, additional variations include portions of the system that are opaque.
- The guide member described herein can be removable from the dilator member or fixed to the dilator member.
- In another variation, the present disclosure includes a dilation system for use with an endoscope configured to provide remote visualization, the endoscope comprising a visualization end located at a distal portion, the dilation system comprising: a dilator member having a proximal portion, a distal portion, a distal end, and a dilator passage extending from the proximal portion through the distal end, the dilator member further comprising a dilation surface located about an outer surface at the distal portion, where a profile of the dilator surface increases in size along a proximal direction such that insertion of the dilator portion in an opening in tissue dilates the tissue; a guide tube extending from the distal end of the dilator member and having a guide passage in fluid communication with the dilator passage; and where the endoscope is advanceable through the guide tube passage such that the visualization end of the endoscope can be repositioned within the guide tube.
- In an additional variation, the present disclosure includes methods for placement of an endoscope adjacent to a target site. In one example such a method comprises positioning an access device adjacent to an opening in tissue, the access device comprising a guide tube and a dilator member, where the guide tube is coupled to at a distal end of the dilator member; inserting the guide tube of the access device within the opening in tissue; dilating the opening in tissue by advancing the dilator member of the access device through the opening in tissue; and imaging the target site using the endoscope while the endoscope is positioned through the dilator member.
- The method can further include visualizing using the endoscope while inserting the guide tube of the access device within the opening.
- In an additional variation, the method includes an opening in tissue which comprises an opening in a pericardial space.
- In certain variations, the method includes a guide tube is transparent and further comprising visualizing through a wall of the guide tube using the endoscope. Alternatively or in combination, where the dilator can be transparent and the method further comprises visualizing through a wall of the guide tube using the endoscope.
- In some variations of the method and devices, the endoscope is affixed to the dilator member and where imaging the target site using the endoscope while the endoscope is positioned through the dilator member comprises repositioning the dilator member to reposition the endoscope.
- Variations of the method further include advancing a second endoscope through the guide tube.
- The present methods can include the use of any conventional device to assist in accessing the body. For example, the methods can further include advancing a guidewire through the opening in tissue and where inserting the guide tube comprises advancing the guide tube over the guidewire.
- Variations of the access device and procedures described herein include combinations of features of the various embodiments or combination of the embodiments themselves wherever possible.
-
-
FIG. 1A illustrates a first variation of an endoscopic system or dilation system \ (when the endoscope is a stand-alone added component). -
FIGS. 1B and 1C illustrate additional variations of systems for navigation of an endoscopic device. -
FIGS. 2A to 2C illustrate another variation of a dilation system that can optionally be integrated with an endoscope external to a guide tube of the system. -
FIG. 3 shows another variation of the system similar to that shown inFIG. 2A . In this variation, the system includes two scopes. -
FIGS. 4A-4E illustrates a variation of a process of positioning or placing an endoscope using the system described herein - Methods and devices described herein provide for improved access of regions within the body using remote visualization, such as endoscopes. The improved methods and devices described herein offer improved access to tissue regions within the body, especially those organs in the thoracic cavity. For purposes of illustration, the following example discusses the methods and devices as used when a physician accesses a pericardial space within a thoracic cavity of an individual, however, the devices and methods have applicability to any region in the body where the benefits of the methods and procedures can assist in the procedure.
- Scope based surgical tools (e.g., elongated cannula/tubular devices that allow viewing of internal body tissues) provide surgeons with an ability to view a surgical site through a lens/fiber optic/camera of the scope and also provide an ability to access the surgical site through a working channel of the tool. In some cases, a scope permits the surgeon to access internal body tissue by passing the scope through a small diameter opening, port, or trocar placed in a surface of the body. For convenience, the present disclosure makes reference an endoscope as a scope-based device. However, the inventive devices and methods described herein specifically include the use of any number of scope based devices used for remotely viewing an area of tissue generally similar to an endoscope; for example, any type of rigid or flexible tube with or without a light delivery system and a visualization source that transmits an image to the viewer, and (optionally) a working channel or lumen that permits delivery of an additional device through the scope.
-
FIG. 1A illustrates a first variation under the present disclosure of anendoscopic system 100 or dilation system 100 (when the endoscope is a stand-alone added component). As illustrated thesystem 100 includes adilator member 102 having adistal dilation surface 106 and adilator passage 108 extending therethrough. Aguide tube 104 extends distally from thedilator passage 108 allowing for anendoscope 150 to be advanced therethrough. Theend 110 of theguide tube 104 can be open or can be closed. In the illustrated variation, theend 110 of theguide tube 104 is configured to be atraumatic. - The components of the
system 100 can include any conventional features useful for medical devices and/or procedures. For example, thesystem 100 can be configured for coupling to avisual display 50 for viewing the images transmitted/relayed from thevisualization end 152 of theendoscope 150. In addition, the system can include any number of auxiliary fixtures (such as a fluid source, vacuum source, controller for electrodes/pacing, etc.) In addition, theguide tube 104 and/ordilator member 102 can have steering capabilities or pre-set shapes to assist in navigating the respective component within tissue. -
FIGS. 1B and 1C illustrate additional variations ofsystems 100 for navigation of anendoscopic device 150. As shown, theguide tube 104 can optionally extend through the length of thedilator 102 and can optionally move relative to thedilator 102 as indicated byarrows 112. Furthermore, thedilation surface 106 of the variation shown inFIG. 1B , can be stepped rather than conical (as shown inFIG. 1A ). However, any atraumatic shape can be used for thedilation surface 106.FIG. 1C also illustrates adilator 102 having anadditional dilation feature 114 such as a distensible ornon-distensible balloon 114. - In any of the variations of the systems described herein, one or more of the components can be configured to assist or improve visualization of a target site by the endoscope. For example, the dilator and/or the guide sheath can be fabricated from opaque or transparent materials. Alternatively, or in combination, the dilator and/or guide tube can include a transparent window that assist in visualization by the endoscope.
-
FIGS. 2A to 2C illustrate another variation of a dilation system 100 (that can optionally be integrated with an endoscope 160). In this variation, adilator 102 includes aguide tube 100 extending therethrough with the distal end of theguide tube 110 extending beyond thedilation surface 106 of thedilator 102. However, this variation also includes aninternal endoscope 160 that is adjacent to theguide tube 110. Such a configuration allows theinternal endoscope 160 to provide an unobstructed view (via the display 50) allowing the physician to visualize the tissue adjacent to thedilation surface 106 as the dilator advances. -
FIGS. 2B and 2C illustrate the end of thedilator 102 shown inFIG. 2A . As shown inFIG. 2B , thedilator 102 can include a scalloped opening or one where there are two passages that are parallel. Thepassages FIG. 2B ) or separated (such as those found in a multi-lumen tube). Additional variations of the dilator opening can include various other shapes. However, in the illustrated variation, theopening 114 provides space for the internal scope (as shown inFIG. 2C ). Similar to the variation shown inFIG. 1A , the dilator and/or guide tube may be composed of either opaque or transparent materials. Theinternal scope 160 can be affixed to the dilator as shown inFIG. 2C . Alternatively, thescope 160 can be moveable relative to thedilator 102. -
FIG. 3 shows another variation of thesystem 100 similar to the one shown inFIG. 2A . In this variation, thesystem 100 includes twoscopes dilator member 102 includes an internal scope 160 (either fixed or moveable within the dilator member 102). Anadditional scope 150 can be advanced through theguide member 104 as discussed above with respect toFIG. 1A . The variation shown inFIG. 3 can include an additional monitor/display 52. Alternatively, or in combination, the image generated by bothscopes -
FIGS. 4A-4E illustrates a variation of a process of positioning or placing an endoscope using the system described herein. As show inFIG. 4A , a variation of the procedure usesminimal incisions incision 14 can be made that requires traversing a diaphragm of the individual 1 in order to access the thoracic cavity. In some variations, the procedure can be performed percutaneously. Again, alternate variations of the method can occur in an open surgical procedure or with any number of surgical incisions. The integrated system can be inserted into the patient through any number of conventionally known access methods. -
FIG. 4B illustrates aheart 4 surrounded by apericardium 4 in order to demonstrate an example of a process for placement of a scope using the system described herein. Any number of commercial devices can be used in conjunction with the systems described herein. For example, a commercially available dilator (e.g., for renal applications) can optionally be inserted be to provide access to thepericardium 4. As shown, a physician can percutaneously insert aneedle 20 into thepericardial sac 4 via an initial pericardial incision orentry point 6. Next, under fluoroscopic guidance (optional), aguidewire 22 can be delivered through theneedle 20 into the pericardial space. In another variation, a physician can use an expandable cannula to insert the integrated system disclosed herein. The physician can use this expandable cannula with an initial insertion profile to minimize the size the pericardial opening to enter the pericardium. Once inserted, the physician expands the expandable cannula to allow for insertion of any of the disclosed integrated endoscope systems. -
FIG. 4C illustrates the state where the physician removes theneedle 20 leaving theguidewire 22 in place. Next, the physician introduces asystem 100 adjacent to the site and advances aguide tube 104 over theguidewire 22 through thepericardial incision 6 and into the pericardial space. As illustrated, afirst scope 150 can optionally be inserted through theguide tube 104 to assist the physician by allowing for visualization of the in the pericardial space that is otherwise obscured by thepericardium 4. In some variations of the device theguidewire 22 must be removed to advance thescope 150. In alternate variations, theguide tube 104 is configured to accommodate both a scope and guidewire. Additionally or alternatively, variations of the system including aninternal scope 160 allow the physician visual access to the region adjacent to the distal end of thedilator member 102 and guidetube 104. -
FIGS. 4D and 4E illustrate examples of a dual scope system and a single scope system, respectively. As noted above for those variations, as shown inFIG. 4D , a physician can use aninternal scope 160 that is positioned adjacent to adilation surface 106 of thedilator member 102 for visualization. The physician also has the option of using asecond scope 150 that passes through theguide tube 104.FIG. 4E illustrates an example of the system where thescope 150 is positioned through theguide tube 104. As noted in either ofFIGS. 4D and 4E , the physician can advance thedilator member 102 to further dilate theopening 6. - Once the opening is dilated and the physician inspects the area of interest, the physician can then advance an additional cannula or a hollow sheath the dilator member of the system. Alternatively, a commercial dilator can be advanced over the
dilator member 102 to permit removal of thedilator member 102 and system to prepare the site for further surgical devices. - For example, integrated vacuum coagulation probes provided by AtriCure, Ohio, are examples of devices that can be inserted through the openings provided by the systems described above. Such devices are capable of heating the soft tissue until achieving irreversible injury making the soft tissue non-viable and unable to propagate electrical impulses, mutate, or reproduce. These integrated vacuum coagulation probe embodiments may be in conjunction with the access devices described herein to treat atrial fibrillation, ventricular tachycardia or other arrhythmia substrate, or eliminating cancer in lung, or other soft thoracic tissue by destroying target cells.
- Examples of such probes are disclosed in commonly assigned U.S. publications and patents:
US20060009762A1 entitled VACUUM COAGULATION PROBE FOR ATRIAL FIBRILLATION TREATMENT;US20060200124A1 entitled VACUUM COAGULATION PROBES;US20060206113A1 entitled METHODS FOR COAGULATION OF TISSUE;US20060235381A1 entitled VACUUM COAGULATION PROBES;US2006-0293646A1 entitled VACUUM COAGULATION & DISSECTION PROBES;US20070043351A1 entitled VACUUM COAGULATION PROBES;US20080114354A1 entitled VACUUM COAGULATION PROBES;US20080114355A1 entitled VACUUM COAGULATION PROBES; andU.S. Patent Nos. 6,893,442 entitled VACUUM COAGULATION PROBE FOR ATRIAL FIBRILLATION TREATMENT;U.S. Patent No. 7063698 entitled VACUUM COAGULATION PROBES; the entirety of each of which is hereby incorporated by reference. - Although the present methods and devices have been described in terms of the embodiments above, numerous modifications and/or additions to the above-described preferred embodiments would be readily apparent to one skilled in the art. It is intended that the scope of the present inventions extend to all such modifications and/or additions and that the scope of the present inventions is limited solely by the claims of the invention.
- As has become from the apparent from the above description, the present invention relates to the following aspects:
- 1. An endoscopic system comprising:
- an endoscope configured to provide remote visualization;
- a dilator member having a proximal portion, a distal portion, a distal end, and a dilator passage extending from the proximal portion through the distal end, the dilator member further comprising a dilation surface located about an outer surface at the distal portion, where a profile of the dilator surface increases in size along a proximal direction such that insertion of the dilator portion in an opening in tissue dilates the tissue;
- a guide tube extending from the distal end of the dilator member and having a guide passage in fluid communication with the dilator passage; and
- where the endoscope is advanceable through the guide tube passage such that a visualization end of the endoscope can be repositioned within the guide tube.
- 2. The endoscopic system of
aspect 1, further comprising a second endoscope extending through the dilator member and radially offset from the guide tube. - 3. The endoscopic system of
aspect 2, where the second endoscope comprises a second visualization end exiting at a dilation surface of the dilator member. - 4. The endoscopic system of
aspect 1, where the dilator member is slidable relative to the guide member. - 5. The endoscopic system of
aspect 1, where the guide member is transparent. - 6. The endoscopic system of
aspect 1, where the dilator member is transparent. - 7. The endoscopic system of
aspect 1, where the guide member is flexible. - 8. The endoscopic system of
aspect 1, where the dilator member is flexible. - 9. The endoscopic system of
aspect 1, where the guide member is removable from the dilator member. - 10. The endoscopic system of
aspect 1, where the endoscope is advanceable through the dilator passage. - 11. The endoscopic system of
aspect 1, where the distal end of the guide tube is tapered. - 12. The endoscopic system of
aspect 1, further comprising a second dilator member slidable over the dilator member. - 13. The endoscopic system of
aspect 1, where endoscope further comprises a flexible a body having the visualization end located at a distal portion of the flexible body. - 14. A dilation system for use with an endoscope configured to provide remote visualization, the endoscope comprising a visualization end located at a distal portion, the dilation system comprising:
- a dilator member having a proximal portion, a distal portion, a distal end, and a dilator passage extending from the proximal portion through the distal end, the dilator member further comprising a dilation surface located about an outer surface at the distal portion, where a profile of the dilator surface increases in size along a proximal direction such that insertion of the dilator portion in an opening in tissue dilates the tissue;
- a guide tube extending from the distal end of the dilator member and having a guide passage in fluid communication with the dilator passage; and
- where the endoscope is advanceable through the guide tube passage such that the visualization end of the endoscope can be repositioned within the guide tube.
- 15. The endoscopic system of
aspect 14, further comprising a second endoscope extending through the dilator member and radially offset from the guide tube. - 16. The endoscopic system of aspect 15, where the second endoscope comprises a second visualization end exiting at a dilation surface of the dilator member.
- 17. The endoscopic system of
aspect 14, where the dilator member is slidable relative to the guide member. - 18. The endoscopic system of
aspect 14, where the guide member is transparent. - 19. The endoscopic system of
aspect 14, where the dilator member is transparent. - 20. The endoscopic system of
aspect 14, where the guide member is flexible. - 21. The endoscopic system of
aspect 14, where the dilator member is flexible. - 22. The endoscopic system of
aspect 14, where the guide member is removable from the dilator member. - 23. The endoscopic system of
aspect 14, where the endoscope is advanceable through the dilator passage. - 24. The endoscopic system of
aspect 14, where the distal end of the guide tube is tapered. - 25. The endoscopic system of
aspect 14, further comprising a second dilator member slidable over the dilator member. - 26. A method for placement of an endoscope adjacent to a target site, the method comprising:
- positioning an access device adjacent to an opening in tissue, the access device comprising a guide tube and a dilator member, where the guide tube is coupled to at a distal end of the dilator member;
- inserting the guide tube of the access device within the opening in tissue;
- dilating the opening in tissue by advancing the dilator member of the access device through the opening in tissue; and
- imaging the target site using the endoscope while the endoscope is positioned through the dilator member.
- 27. The method of aspect 26, further comprising visualizing using the endoscope while inserting the guide tube of the access device within the opening.
- 28. The method of aspect 26, where the opening in tissue comprises an opening in a pericardial space.
- 29. The method of aspect 26, where the guide tube is transparent and further comprising visualizing through a wall of the guide tube using the endoscope.
- 30. The method of aspect 26, where the dilator is transparent and further comprising visualizing through a wall of the guide tube using the endoscope.
- 31. The method of aspect 26, further comprising advancing the endoscope through the dilator member.
- 32. The method of aspect 31, further comprising advancing the endoscope through the guide tube.
- 33. The method of aspect 26, where the endoscope is affixed to the dilator member and where imaging the target site using the endoscope while the endoscope is positioned through the dilator member comprises repositioning the dilator member to reposition the endoscope.
- 34. The method of aspect 33, further comprising advancing a second endoscope through the guide tube
- 35. The method of aspect 26, further comprising advancing a guidewire through the opening in tissue and where inserting the guide tube comprises advancing the guide tube over the guidewire.
- 36. The method of aspect 26, where the dilator member is moveable over guide tube.
- 37. The method of aspect 36, further comprising removing the dilator from the guide tube and advancing a second dilator over the guide tube.
- 38. The method of aspect 36, further comprising advancing a hollow member over the dilator and removing the dilator from the opening in tissue.
- 39. The method of aspect 38, further comprising advancing one or more medical devices through the hollow member.
- 40. The method of aspect 26, wherein the dilator comprises an expandable member.
Claims (15)
- A dilation system for use with an endoscope configured to provide remote visualization, the endoscope comprising a visualization end located at a distal portion, the dilation system comprising:a dilator member having a proximal portion, a distal portion, a distal end, and a dilator passage extending from the proximal portion through the distal end, the dilator member further comprising a dilation surface located about an outer surface at the distal portion, where a profile of the dilation surface increases in size along a proximal direction such that insertion of the dilator member in an opening in tissue dilates the tissue;a guide tube extending from the distal end of the dilator member and having a guide tube passage in fluid communication with the dilator passage; andwhere the endoscope is advanceable through the guide tube passage such that the visualization end of the endoscope can be repositioned within the guide tube.
- The dilation system of claim 1, further comprising a second endoscope extending through the dilator member and radially offset from the guide tube.
- The dilation system of claim 2, where the second endoscope comprises a second visualization end exiting at a dilation surface of the dilator member.
- The dilation system of claim 1, where the dilator member is slidable relative to the guide tube.
- The dilation system of claim 1, where the guide tube is transparent.
- The dilation system of claim 1, where the dilator member is transparent.
- The dilation system of claim 1, where the guide tube is flexible.
- The dilation system of claim 1, where the dilator member is flexible.
- The dilation system of claim 1, where the guide tube is removable from the dilator member.
- The dilation system of claim 1, where the endoscope is advanceable through the dilator passage.
- The dilation system of claim 1, where the distal end of the guide tube is tapered.
- The dilation system of claim 1, further comprising a second dilator member slidable over the dilator member.
- The dilation system of claim 1, wherein the guide tube is independently manipulable from the endoscope when the guide tube is advanced distally through the dilator passage.
- The dilation system of claim 13, wherein the guide tube maintains a tubular shape when advanced through the dilator passage.
- The dilation system of claim 13, wherein the guide tube is advanced past the distal end of the dilator member.
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Also Published As
Publication number | Publication date |
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EP3294107A4 (en) | 2019-06-12 |
US20160331207A1 (en) | 2016-11-17 |
US12023010B2 (en) | 2024-07-02 |
EP3294107B8 (en) | 2023-11-08 |
EP4233977A3 (en) | 2023-10-04 |
WO2016183503A1 (en) | 2016-11-17 |
EP3294107B1 (en) | 2023-10-04 |
HK1254157A1 (en) | 2019-07-12 |
JP2018519879A (en) | 2018-07-26 |
US20230021205A1 (en) | 2023-01-19 |
EP3294107A1 (en) | 2018-03-21 |
CN107920719B (en) | 2020-04-24 |
CN107920719A (en) | 2018-04-17 |
EP3294107C0 (en) | 2023-10-04 |
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